The Recall Desk

Manufacturer

Z-Medica, LLC

3 recalls in our database name Z-Medica, LLC as the manufacturing or recalling firm.

What the numbers show

Total
3
Critical
0
Severe
0
Most recent
2021-11-17

Of the 3 recalls from Z-Medica, LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–3 of 3

  • HighFDA (Devices)·Z-0211-2022·2021-11-17

    QuikClot Combat Gauze Recalled for Potential Sterile Packaging Seal Failure

    Z-Medica is recalling 2400 units of QuikClot Combat Gauze due to potential packaging seal failures that could compromise sterile barrier integrity. Affected lot 12645 was distributed nationwide.

    Product
    QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding Model / Part# 200
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0925-2018·2018-03-14

    Z-Medica Recalls QuikClot TraumaPad Dressings Due to Labeling Error

    Z-Medica is recalling 4,890 units of QuikClot TraumaPad dressings because one pouch in a box was mislabeled as a different product, though the contents were correct.

    Product
    QuikClot TraumaPad, Part# 460 a topical dressing for local management of bleeding wounds such as cuts, lacerations, and abrasions. It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatological, etc.) and
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2612-2017·2017-06-28

    Z-Medica Recalls QuikClot TraumaPad Due to Packaging Sterility Concerns

    Z-Medica is recalling 2,910 units of QuikClot TraumaPad hemostatic dressings because packaging breaches may compromise sterility.

    Product
    QuikClot TraumaPad, , sterile, soft, white, X-ray detectable hemostatic dressing Part Number 460 Manufactured by Z-Medica, LLC 4 Fairfield Boulevard, Wallingford, CT 06492 USA For use as a topical dressing for local management of bleeding wounds such as cuts, lacerations, an
    Category
    Medical Device
    Distribution
    Distributed nationwide